Manager – Regulatory Affairs Operations
Posted on 1/12/2023
Editas Medicine

51-200 employees

Cambridge, MA, USA
Experience Level
Desired Skills
Operations & Logistics
  • Ability to rapidly adapt to different issues and projects at one time. Expert in planning and delivering work on time keeping quality parameter in mind
  • Knowledge of regulatory procedures in appropriate region
  • Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions
  • Develop understanding of different TAs due to assignment to different projects
  • Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape
  • Increased exposure to global and multi-functional teams
  • Good working knowledge of regional regulatory intelligence
  • Ability to work closely with client regional heads to determine the Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable
  • Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable
  • Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements
  • Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, publishing projects
  • Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
  • Proficient with relevant submission software, including but not limited to, Veeva, Adobe Acrobat, Microsoft Office, eCTD viewers
  • Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine)
  • Bachelor's degree in related discipline and a minimum of 5 years of related experience; or
  • Master's degree in related discipline and a minimum of 3+ years of related experience; or
  • PhD degree in related discipline and a minimum of 2 years of related experience; or Equivalent combination of education and experience
  • Demonstrates a high-level of self-motivation and professional commitment
  • Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
  • Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
  • Provide operational support on strategic regulatory documents to help drive timely deliverables
  • Drive operational excellence in Regulatory Strategy & Policy through projects aimed to support collaboration and improve efficiency
  • Additional responsibilities, in conjunction with regulatory leads and regulatory CMC lead, include BLA maintenance submissions
  • Safety and Annual report submissions (regulatory components)
  • Coordinating and drive rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of response to HA queries according to the rapid response process
  • Maintaining global submission plans and supporting those plans can be executed on time
  • Coordinating and driving global regulatory sub team meetings to ensure high quality meeting discussions & outputs; this includes diligent follow-up with sub team members to uphold accountabilities and drive decision-making